Events

Recall of Device Recall CoatACount TSH IRMA IKTS1 with calibrator TSI3X Lot 035

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63852
  • Event Risk Class
    Class 3
  • Event Number
    Z-0646-2013
  • Event Initiated Date
    2012-11-28
  • Event Date Posted
    2013-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114905
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Reason
    The recall was initiated because siemens healthcare diagnostics confirmed an under-recovery of dose values with some vials of coat-a-consta (cac) irma tsh calibrators tsi4 (level b), tsi5 (level c), tsi6 (level d), tsi8 (level f), and tsi9 (level g) lot 035. the affected calibrator vials can be identified by a darker yellow color than normal. the tsi3 (level a), tsi7 (level e), and tsix (level h).
  • Action
    Siemens sent an Urgent Medical Device Recall letter dated November 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, complete and return the Urgent Medical Device Recall Effectiveness Check form included with the letter by fax to 302-631-7597. Customers were also instructed to determine their replacements needed, and to forward the recall letter to whomever they may have distributed the affected product. For questions customers were instructed to contact their Siemens Technical Solutions Ceter or their local technical support representative. For questions regarding this recalla call 914-524-2955.

Device

Device Recall CoatACount TSH IRMA IKTS1 with calibrator TSI3X Lot 035
  • Model / Serial
    Lots 969 and 970
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,
  • Product Description
    Immunoradiometric assay. || Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA